Nalbuphine hydrochloride
- Product NDC
- 71872-7331
- 11-digit product format
- 718727331
- Labeler code
- 71872
- Product ID
- 71872-7331_292b0d0e-f223-d384-e063-6394a90acd44
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Nalbuphine hydrochloride
- Dosage form
- INJECTION
- Route
- INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Medical Purchasing Solutions, LLC
- Application
- ANDA216049
- Marketing category
- ANDA
- Marketing start
- 2024-09-26
- Substance
- NALBUPHINE HYDROCHLORIDE
- Active strength
- 10 mg/mL
- Pharmacologic classes
- Competitive Opioid Antagonists [MoA], Opioid Agonist/Antagonist [EPC], Partial Opioid Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Nalbuphine hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NALBUPHINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | ZU4275277R |
| Rxcui | 904415 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 71872-7331-1 | Nalbuphine hydrochloride | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 1 |
| 71872-7331-1 | Nalbuphine hydrochloride | 1 in 1 BAG | INJECTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71872-7331 | NALBUPHINE HYDROCHLORIDE INJECTION [MEDICAL PURCHASING SOLUTIONS, LLC] | 1 | Current NDC, 2 package rows | 20241215_292b0d0e-f222-d384-e063-6394a90acd44.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 71872-7331-1 | 71872733101 | 1 VIAL, MULTI-DOSE in 1 BAG (71872-7331-1) / 10 mL in 1 VIAL, MULTI-DOSE | 2024-11-15 | No | No | Current |